Diabetes Care Host-Client Architecture and Data Management System

ABSTRACT

A host-client data sharing system manages diabetes care data. A host database, preferably web or internet based, is implemented for storing diabetes care data relating to multiple diabetics. A client or local database stores the diabetes care data relating to multiple diabetics on a personal appliance such as a PC, or a portable or handheld microprocessor-based computing device. The host database uses multiple servers for handling client interactions with the system.

PRIORITY

This application claims the benefit of priority under §35 USC 119(e) toU.S. provisional patent application Ser. No. 60/577,064, filed Jun. 4,2004, which is hereby incorporated by reference.

FIELD OF THE INVENTION

The invention relates to diabetes care data management, and particularlyto a host-client architecture for communicating, managing and analyzingthe data and for generating versatile reports.

SUMMARY OF THE INVENTION

The invention provides a host-client data sharing system for managingdiabetes care data. a host database, preferably web or internet based,is implemented for storing diabetes care data relating to multiplediabetics. A client or local database stores the diabetes care datarelating to multiple diabetics on a personal appliance such as a PC, ora portable or handheld microprocessor-based computing device. The hostdatabase uses multiple servers for handling client interactions with thesystem. A host based data warehouse component is used for storing,searching and/or analyzing, customer information and health data storedon the host database for the population of multiple diabetics using theHost. The host-based data warehouse component applies securitymechanisms to protect access to the data stored on the host server. Thedata mining terminal runs an analytical data processing application andhas access to the data warehouse.

A browser-accessible or client-resident graphics rendering componentprovides a graphical user interface (GUI) that includes a patientselection component permitting uploading data to or calling data from,the database, or both, relating to a particular diabetic of the multiplediabetics. The GUI further includes diabetes care device and health careprofessional (HCP) selection components, and report configurationcomponents for generating customized reports of selected diabetics,HCPs, data ranges, data types or categories and other criteria.

Population analysis reporting or generation of reports on a populationof multiple diabetics is permitted with the report generation component.These reports are allowed to base the data analysis on multipleselection criteria. These data elements may be applied in a selectedcombination and may use a selected number of selection criteria, such aspatient profile information, demographic information, selected dataevent types, a range of values for a given selection criteria, dates, orother data filters or elements. The report may then be ordered using aselected column or field in the resulting report. Multiple Filter/searchcriteria may be stored together or individually, and then selectivelyapplied and turned off in the resulting display. A pattern recognitioncomponent for the resulting display uses the GUI (color or otherhighlighting) to draw the user's attention to determining whetherpatterns of interest exist within the data and for indicating anyrecognized patterns.

Diabetes related health information may be overlayed in a particularform of report. In a weekly Pump Report, a combination of insulin data(which may be derived from an insulin pump) is provided in a weeklyformat summarizing each day in a one week period where the GUI isdivided left to right by day with vertical demarcation, and containingdata analysis statistics that include insulin information, glucoseinformation and/or carbohydrate information, among other data typesdescribed herein, summarized in each day's column. In a dailycombination report, a combination of Glucose, insulin and/orcarbohydrate data, or other data type, may be provided in an hourlyformat summarizing one full day, where the GUI is divided left to rightby hour with vertical demarcation, and containing data analysisstatistics that include insulin information, glucose information andcarbohydrate information summarized into each hour's column. For eachreport, whether it be monthly, weekly, daily or another selectedtemporal duration, the report may include graphical charts or picturesor text-based analytical information, or a combination of these. Thestatistics and analytical information shown can be adjusted for pumpusers and non pump users depending on the insulin data type.

The system provides an ability to tracking a large number of health anddemographic elements on a same report. These may include glucose,insulin, meals, exercise, state of health, medication, medical exam, labresult, ketones, or combinations thereof. These elements may bedisplayed in a graphical or text based (charts) or in a tabular form.Reports may be filtered, grouped or sorted by any of the fieldsassociated with these events. Multiple criteria may be applied to asingle patient's data or multiple patients' data.

The system provides a data sharing feature including a synchronizationarchitecture by which a diabetic client may share data useful inmanagement of the diabetic condition with selected health careprofessionals. This architecture may be implemented through anInternet-based synchronizing server. The system can handle incrementallyadded or modified data that is synchronized to the internet-basedserver. This features saves having to copy a full database each time asynchronization operation is requested. A security process assures thatdata is shared only as authorized by the original user and is acceptedby the sharing health care professional.

The system provides for storing packets of new or modified data on theInternet-based synchronizing server. The system of stored packets of newor modified data can be organized into a database for meaningful viewingand analysis of the contained data. A diabetic client may maintain datauseful in management of the diabetic condition in two or more physicallyseparate locations and/or computers and by which this data may besynchronized to be identical on the multiple locations and/or computers.

Data protection is provided by which a diabetic client may store back-upcopies of data useful in management of the diabetic condition in aremote, protected internet server location.

Local area networking provides a mechanism by which multiple clientcomputers may store and retrieve data useful in management of diabetesfrom a single server database in a local area networking environment.

Synchronizing internet computer scalability is provided for distributingstored synchronizing diabetes management data across multiple servercomputers in order to scale the capacity of the system. A clientdatabase is also synchronized within the system. Traffic to the multipleservers is managed for storing synchronizing diabetes management datathat balances the load more or less equally among the various multipleavailable servers.

A host email system permits the host to send email messages notifyinghost users of upgrades, or other health or product information orupgrades. A user may also upload from a compatible device andimmediately or subsequently print out any or all of the availablereports (or specific multiple reports) in a desired date range (dateranges apply specifically to each report) with any personal printingpreferences specified. In one embodiment, a user profile may be createdfirst, while selection of report generation and printing preferences maybe manually applied or automatically selected based on past history orother default criteria.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1. Home Page

FIG. 2. Application Installation Screen

FIG. 3. Installation Destination Screen

FIG. 4. Select Program Manager Group Screen

FIG. 5. Start Installation Screen

FIG. 6. Finish Screen

FIG. 7. Location of Start Button (PC Desktop) and Programs List

FIG. 8. Initial User Setup Screen

FIG. 9. Home Page

FIG. 10. HCP Version: Select HCP and Select Patient Fields

FIG. 11. File Drop-Down Box: System Settings

FIG. 12. System Settings Screen

FIG. 13. Logon to System Screen

FIG. 14. Home Page: UserProfile Drop-Down Box

FIG. 15. User Information Screen

FIG. 16. Health Profile Screen

FIG. 17. Condition Drop-Down Box

FIG. 18. Date Diagnosed Drop-Down Calendar

FIG. 19. Data Entry Preferences Screen

FIG. 20. Glucose Target Ranges Screen: Standard Mode

FIG. 21. Glucose Targets Mode Drop-Down Box

FIG. 22. Pre/Post Meal Mode with Hypo/Hyper Checked (left); All TimePeriods Mode (right)

FIG. 23. Hypo/Hyper Values Check Box

FIG. 24. Time Periods

FIG. 25. Time Period Error Message

FIG. 26. Glucose Unit of Measure Drop-Down Box

FIG. 27. Options Screen

FIG. 28. User Rights Screen

FIG. 29. File Drop-Down Box: Add User

FIG. 30. User List Screen

FIG. 31. Error Message

FIG. 32. Home: UserProfile Drop-Down Box

FIG. 33. User Rights Screen

FIG. 34. File Menu Drop-Down Box: Add HCP

FIG. 35. HCP Profile Screen

FIG. 36. HCP Type Drop-Down Box

FIG. 37. UserProfile Drop-Down Box: HCP List

FIG. 38. HCP List Screen

FIG. 39. HCP Home Page

FIG. 40. HCP: UserProfile Drop-Down Box

FIG. 41. HCP User Information Screen

FIG. 42. Glucose Target Ranges Screen: Standard Mode

FIG. 43. Glucose Targets Mode Drop-Down Box

FIG. 44. Pre/Post Meal Mode with Hypo/Hyper Checked (left); All TimePeriods Mode (right)

FIG. 45. Hypo/Hyper Values Check Box

FIG. 46. Glucose Unit of Measure Drop-Down Box

FIG. 47. HCP Profile Options Screen

FIG. 48. User Rights Screen

FIG. 49. HCP: UserProfile Drop-Down Box

FIG. 50. Patient List Screen

FIG. 51. Patient Profile Screen

FIG. 52. Patient List Screen

FIG. 53. Patient List Screen

FIG. 54. Assign Patients Drop-Down Box

FIG. 55. Authorization Levels

FIG. 56. HCP: File Drop-Down Box

FIG. 57. HCP List Screen

FIG. 58. Reassign Local Patients Message

FIG. 59. User Rights Screen

FIG. 60. Cable Connection Example

FIG. 61. Home Page with Select User Drop-Down List

FIG. 62. DataEntry Drop-Down List: Device Setup

FIG. 63. Device Setup Screen

FIG. 64. Device Setup Screen with Details

FIG. 65. DataEntry Drop-Down List: Read Device

FIG. 66. Assign Device Screen

FIG. 67. Summary Window

FIG. 68. DataEntry Drop-Down List: Undo Last Upload

FIG. 69. DataEntry Drop-Down List: Read Tracker

FIG. 70. Read Tracker Screen: HotSync Prompt

FIG. 71. HotSync Progress Screen

FIG. 72. Assign Device Screen

FIG. 73. Profile Updated Screen

FIG. 74. Upload Summary Screen

FIG. 75. Reports Drop-Down List: Diary List

FIG. 76. Glucose Reading Data Entry Screen

FIG. 77. Insulin Data Entry Screen

FIG. 78. Meal Data Entry Screen

FIG. 79. Multi-Item Meal with Total Carbs Shown

FIG. 80. Exercise Data Entry Screen

FIG. 81. State of Health Data Entry Screen

FIG. 82. Medication Data Entry Screen

FIG. 83. Medical Exam Data Entry Screen

FIG. 84. Lab Test Result Data Entry Screen

FIG. 85. Ketones (Blood) Data Entry Screen

FIG. 86. Sample Site Drop-Down Box

FIG. 87. Notes Data Entry Screen

FIG. 88. DataEntry Drop-Down Box: Customize Data Entry Lists

FIG. 89. Select List to Customize Drop-Down List

FIG. 90. Exercise Types

FIG. 91. Food List

FIG. 92. Insulin Names List

FIG. 93. Test Types List

FIG. 94. Medications List

FIG. 95. Exam Types List

FIG. 96. DataEntry Drop-Down Box and Import Drop-Down Box

FIG. 97. File Browser Window: Select Database to Import

FIG. 98. Import Drop-Down Box: Activate FreeStyle CoPilot I Data

FIG. 99. Import Drop-Down List: Import Events From File

FIG. 100. File Browser Window

FIG. 101. Reports Drop-Down Box

FIG. 102. Diary List: Date Adjustment

FIG. 103. File Browser Window

FIG. 104. Reports Window: Glucose Modal Day Report (Default Report)

FIG. 105. Reports Drop-Down Box

FIG. 106. Glucose Line Report Active with Several Other Open Reports

FIG. 107. Reports Toolbar (Date Range)

FIG. 108. Print Drop-Down Box

FIG. 109. User Profile Screen with Options Tab Active

FIG. 110. Report Configuration Screen: Data Filter Tab

FIG. 111. Report Configuration Screen: Miscellaneous Tab

FIG. 112. Black-and-White Display: Distinctive Patterns (Screen Detail)

FIG. 113. Diary List

FIG. 114. Reports: Right-Click Pop-Up Menu

FIG. 115. Customization List

FIG. 116. Glucose Modal Day Report (Dotted Line Linking Readings forApr. 3, 2004)

FIG. 117. Glucose Line Report (Show Line Is Activated)

FIG. 118. Pop-up Menu: Glucose Line Report

FIG. 119. Glucose Average Report: By Meal

FIG. 120. Glucose Average Report: By Day

FIG. 121. Glucose Histogram Report

FIG. 122. Glucose Pie Chart Report: Total Readings Pie Chart

FIG. 123. Glucose Pie Chart Report: Ten Summary Pie Charts

FIG. 124. Logbook Report

FIG. 125. Lab & Exam Record Report: Lab Record

FIG. 126. Lab & Exam Record Report: Exam Record

FIG. 127. Lab & Exam Record Report: A1C History

FIG. 128. Statistics Report: Glucose Statistics

FIG. 129. Statistics Report: Insulin and Carbs Statistics Tables

FIG. 130. Date Field for Selecting Date

FIG. 131. Daily Combination View Report: Glucose Line and CarbohydratesGraphs

FIG. 132. Daily Combination View Report: Insulin Summary and Data Table

FIG. 133. Date Field for Selecting Date

FIG. 134. Weekly Pump View Report: Bar Graph

FIG. 135. Weekly Pump View Report: Pie Charts and Glucose StatisticsTable

FIG. 136. HCP Group Analysis Report

FIG. 137. Pop-Up Window

FIG. 138. Customization List

FIG. 139. Filter Builder Screen

FIG. 140. References Drop-Down Box

FIG. 141. Insulin Adjustment Table

FIG. 142. Prescribed Plan

FIG. 143. Home User: Host Drop-Down Box (left); HCP User: Host Drop-DownBox (right)

FIG. 144. First Time Synchronization Screen

FIG. 145. Host Account Number

FIG. 146. Synchronization Summary Screen

FIG. 147. Confirmation Message From the Host

FIG. 148. Invite to Share Data (Home User Screen, left; HCP User Screen,right)

FIG. 149. Invite HCP to Share Data Screen

FIG. 150. Find HCP from Existing Accounts Screen

FIG. 151. Assign Access Level Screen

FIG. 152. Process Complete Screen

FIG. 153. Invite HCP to Share Data Screen

FIG. 154. Enter Host HCP Account Number Screen

FIG. 155. Assign Access Level Screen

FIG. 156. Process Complete Screen

FIG. 157. Messages from CoPilot Host Window

FIG. 158. Invitation to Share Data (from Host)

FIG. 159. Invite HCP to Share Data Screen

FIG. 160. E-mail Invitation to HCP with No Host Account

FIG. 161. Assign Access Level

FIG. 162. Process Complete Screen

FIG. 163. E-mail Invitation to Register and Share Data

FIG. 164. Invitation Code Example

FIG. 165. HCP: Host Drop-Down List

FIG. 166. Accept Invitation Screen

FIG. 167. Synchronization Screen

FIG. 168. Home User: Host Drop-Down Box

FIG. 169. Manage My Shared Data Screen

FIG. 170. HCP User: Host Drop-Down Box

FIG. 171. Manage Data Being Shared With Me Screen

FIG. 172. Changed Access Level Message

FIG. 173. File Drop-Down Box: Database Maintenance Submenu

FIG. 174. Archive Event Data Screen

FIG. 175. File Browser Window: Save Archive Data

FIG. 176. File Browser: Location of Archived Data File (*.xml)

FIG. 177. DataEntry Drop-Down Box: Import Submenu

FIG. 178. Importing Screen

FIG. 179. File Browser: Select Backup Location

FIG. 180. Restore Log

FIG. 181. File Browser: Restore Log

FIG. 182. Help Drop-Down List

FIG. 183. Help Screen

FIG. 184. Help: Index Tab

FIG. 185. Help: Search Tab

FIG. 186. Help Drop-Down Box

FIG. 187. Customer Service Contact Information Screen

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A system in accordance with a preferred embodiment is referred to as theFreeStyle CoPilot™ Health Management System (also referred to as theFreeStyle CoPilot System or the System), and is a personal computer (PCor portable or handheld appliance)-based software application thatpermits people with diabetes, their healthcare team, and caregivers toupload data preferably from FreeStyle™ and Precision Xtra™ blood glucosemonitoring systems (and generally to several other commerciallyavailable blood glucose meters and insulin pumps) into the FreeStyleCoPilot application.

The FreeStyle CoPilot System provides graphs and other software toolsfor people with diabetes and their healthcare professionals (HCPs) tohelp evaluate and analyze glucose readings, carbohydrate intake, insulindosage, and other diabetes-related factors uploaded from devices ormanually entered into the System. The System can help identify trendsthat can be used to educate persons with diabetes to improve theirglucose control.

Common terms that have additional special meanings within the FreeStyleCoPilot System are capitalized to distinguish their special usage (forexample, Diary as opposed to a written diary). System-specific screen,control, commands, and function names (for example, Home page, the Applybutton) are also capitalized throughout. The specific usages of theseterms within the system of the preferred embodiment is intended to beadded to their ordinary meanings and usages to enlarge the scopes ofthese terms in the context of the invention, and not to limit them.

The FreeStyle CoPilot Health Management System provides an accessory toa blood glucose monitoring system such as the FreeStyle and PrecisionXtra blood glucose monitoring systems and other commercially availableblood glucose meters and insulin pumps. The FreeStyle CoPilot HealthManagement System may be used in home and clinical settings to uploaddata from these devices to a patient's or healthcare professional'scomputer where the data may be saved, displayed in a number of formats,printed, or exported to an authorized user. The FreeStyle CoPilot Systemis an aid to people with diabetes and healthcare professionals in thereview, analysis, and evaluation of historical blood glucose testresults, insulin dosages, and carbohydrate intake data to support aneffective diabetes management program. The System may be used in homeand healthcare professional settings to manage diabetes factors, such asinsulin dosage, carbohydrate intake, and exercise.

There are two primary users contemplated for the System: home users(people with diabetes or their caregivers), and HCP users (healthcareprofessionals). A home version of the software for a person withdiabetes or the caregiver of a person with diabetes may permit recordinginformation for them such as glucose, insulin, meals, exercise and/orother data types described herein. A HCP version of the software is formanaging health data provided to a HCP by one or more patients withdiabetes. HCP can mean an individual healthcare professional (such asphysician, nurse educator, or other diabetes healthcare team member), agroup or entity (such as a clinic), or even case managers, medicaldirectors, and other managed care professionals, if authorized by theperson with diabetes. The System may be used to monitor the healthstatus of the patients they manage.

The System is a personal computer (PC) or personal computing appliancesoftware application that enables users to upload, store, and/or analyzeglucose readings and other important information for diabetesmanagement. This information can be used by people with diabetes, theirhealthcare professionals (HCPs), and caregivers.

After installing the System on a PC or PC appliance, glucose data can beuploaded or copied from a compatible glucose meter, or data can typed infrom a keyboard, or imported from a file. One can maintain a record ofhis or her glucose, carbohydrates, insulin, exercise, state of health,doctor visits, medications, blood ketones, and/or laboratory results.One may enter as much or as little information as desired.

The System analyzes the data and displays it in simple, clear reports(graphs and tables). The reports can be viewed on the computer screen oron the display of the computing appliance or they can be printed out(black-and-white or color). One can also automatically print one or morereports that are selected to be printed or displayed each data isuploaded from a particular device.

The System further allows permits data sharing securely over theInternet with selected HCPs. The System further promotes teamwork foreffective diabetes health management. The System encourages people withdiabetes to stick to lifestyle recommendations and medication plans. Itcan help them and their HCPs to identify trends in health or care.

The System preferably utilizes a personal computing desktop, portable orhandheld appliance with 400 megahertz (MHz) or higher processor clockspeed recommended. The system preferably includes either an internetconnection or a compact disc (CD-ROM) drive or other digital storagedevice interface. Random access memory (RAM) of 64 megabytes (MB) ormore is recommended, while available hard disk space of 30 MB is usedfor running the program. Microsoft® Windows 98 SE, 2000, NT, ME, or XPoperating systems are preferred. A monitor with 1024×768 or higherresolution is preferred. A standard keyboard and mouse are alsopreferred, or other input device that may be utilized with a particularpersonal computing appliance.

A few optional accessories that can be useful in combination with theSystem include a serial port, available 9-pin EIA-232 (also known asRS-232 or V.24) or appropriate adapter for a universal serial bus (USB)for glucose meter connection, a Windows-compatible printer for printingcopies of reports, a Windows-compatible fax software and drivers forfaxing reports, an email application for e-mailing reports, data cablesfor uploading from compatible devices, and a HotSync® cradle foruploading data from a PDA-type diabetes management system.

The System is preferably available as a download from a web site such asthe FreeStyle CoPilot website (www.freestylecopilot.com), and/or on a CDpurchased through a website or customer care center.

Using the System, a diabetic or HCP can read (upload) or export datafrom devices such as glucose meters and insulin pumps. These devices canbe connected to the System by serial port or USB.

Graphical User Interface

Display screens of the System preferably have a consistently similarlook and structure. Common screen icons are preferably organized on aHome page, such as that illustrated in FIG. 1, with the main useractivities highlighted. The screen shot illustrated at FIG. 1 includes amain menu bar 2, a small icons bar 4, large buttons 6, and name of opendatabase 8.

Tabs on the main menu bar 2 enable access to program activities. Thesmall icons 4 and large buttons 6 represent a subset of the programactivities including commonly used activities. Clicking on a tab of themain menu bar 2, a small icon 4, or a large button 6 opens acorresponding screen. The Home page is described in more detail belowwith reference to FIG. 9.

The System can as a stand-alone product operated by itself on a user'sPC and can serve as a self-management tool for the collection andanalysis of diabetes-related data. The System can also be used by HCPsin an office or clinic. The System can also operate in a LANenvironment. In this case, a central database is preferably installed onthe LAN server, wherein each computer in the network can access andreview this central database.

For users who want to communicate and share data remotely, the Systemhas a Host server on the internet that acts as a processing, storage,and routing center for the files of users who choose to use thesecommunication and data access capabilities. A user may choose tosynchronize with the Host via internet access from a PC or other capabledesktop, portable or handheld appliance (hereinafter simply referred toas PC). The communication can occur between people with diabetes andtheir HCPs or among HCPs.

Users (Home and HCP) can share data by synchronizing. Synchronizationallows each user to update and match the data they track. The processincludes sending data from a PC to a Host server. The Host server actsas the central database for the System. When a user synchronizes theclient System with the Host server, diabetes data, notes, comments, newentries, and edits entered into the client System are mirrored on theHost server and client PC. Each party sharing data preferablysynchronizes regularly with the Host server to stay current.

The System software can be installed by downloading the program from theInternet, or installing the program from a CD or other digital storagedevice. FIG. 2 illustrates a screen shot of an application installationscreen.

FIG. 3 illustrates an installation destination screen. A user mayinstall the System on a selected device. If installing the program on alocal area network (LAN), synchronizing with a network administrator ispreferred. At a select program manager group screen, such as thatillustrated at FIG. 4, a suggested program manager group 10 or anotherselected from a scroll-down list 12, may be selected. A startinstallation screen such as that illustrated at FIG. 5 permits thesoftware to be installed. If the installation is successful in fullyinstalling the System, a final setup screen then displays, such as thatillustrated at FIG. 6. A System icon will now appear on the PC desktop,and System program and user guides are added to the PC's Programs list.

FIG. 7 illustrates location of Start Button 14 (PC Desktop) and ProgramsList 16 within Windows™. The system program files and guides menuoptions 18 can be accessed this way.

A User Profile can now be set up, as described in more detail below.Setting up a User Profile allows a diabetic to take full advantage ofadvantageous features of the System. The process begins with an initialuser set up screen, such as that illustrated at FIG. 8, if this is thefirst time a user is running the program. The user may select Home User20 if he or she is a person with diabetes, or Health Care Professional22 if he or she is a HCP. Personal identification information includinga password is then input in a user identification section 24. Afterfilling in the Initial User Setup information, this screen is notutilized again, and instead a home page, such as that illustrated atFIG. 9, will display when the System program is run.

Home Page

From the Home page, a diabetic or HCP can access multiple advantageousfeatures of the System, either by clicking a small icon 4 or a largebutton 6, or by selecting a tab on the main menu bar 2.

A select user field 24 is illustrated in FIG. 9. The name of the activeuser is displayed in the Select User field 24. The select user filed 24includes a drop-down list of multiple persons each having a User Profilein the System. Referring to FIG. 10, in a HCP version, there is a SelectHCP field 26 and a Select Patient field 28.

The small icons 4 provide access to program functions. From left toright in FIG. 9, preferred small icons 4 include: a go to home pageicon, a read data from a meter icon, a manually enter data icon, a viewreports icon, a synchronize with host icon, and edit current user'sprofile or edit current patient's profile icon, and a show context helpicon.

The Large Buttons 6 provide quick access to main program functions. Fromleft to right in FIG. 9, preferred large icons 6 include: a User List orpatient list icon a Read Device icon, a Manual Entry icon, a ViewReports icon, and a User Profile or Patient Profile icon.

When the client is synchronized with the Host computer via the Internet,messages are preferably sent from the Host that may include informationabout data sharing, healthcare management, and updates to the System.

A Resource Links section provides options to take a user directly toresources available as the System website. These may include Ask theDiabetes Educator, Diabetes News, Check for Software Updates and ContactTech Support. Contact tech support is preferably an email support optionthat, upon clicking, will result in a pop-up window either informing theuser that a “local mail client” is not available or will supply the userwith the e-mail address for Customer Service/Tech Support.

A Turning On Password Protection option is for users desiring to protecttheir data (and their privacy) by requiring the entry of a User ID andPassword each time they start the System or each time they select adifferent user in the Select User field (Home version) or the Select HCPfield (HCP version). To turn on password protection, on the Home page, auser may select System Settings from the File drop-down box (see FIG.11). If System Settings is grayed out, then a user does not have theUser Rights to turn on password protection. If a user does have UserRights, then the System Settings screen displays (see FIG. 12). When thebox to Require User Logon is checked, then password protection is turnedon and the first screen will be a Logon to System screen (see FIG. 13).This screen will also display when changing users in the Select Userfield (Home version) or in the Select HCP field (HCP version). The homepage will appear upon typing in or otherwise inerting a User ID andPassword.

For a home user to take advantage of many features of the program, auser should set up a Home User Profile. This allows the user and HCP, ifselected, to enter data and create reports to monitor trends in thehealth or care of the diabetic user.

FIG. 14 illustrates a home page having a UserProfile tab on the mainmenu bar 2 selected and expanded. The User Profile button of the largeicon bar 6 may also be clicked. Either way, User Profile may be nowselected from the drop-down box 30 or other menu expansion architecture.

A Profile For screen is illustrated in FIG. 15. In the screen display ofFIG. 15, the User Information tab 32 is selected. A user may providewhatever information that he or she wishes to, except that fields markedwith an asterisk (*) or double-asterisk (**) will be required fields.Information can be added by selecting items from drop-down boxes or bytyping in words and numbers. A Health Profile tab is illustrated at FIG.16. When a Condition column arrow is clicked, a drop-down box isdisplayed such as that illustrated at FIG. 17. The user can select anyof the conditions listed that apply to him or her, or type in a newcondition that will be added to the list.

A screen shot such as that illustrated at FIG. 18 will appear when thearrow on a Date Diagnosed column is clicked. The screen shot of FIG. 18is preferably a basic calendar. The arrows may be used to select thedate this condition was diagnosed.

FIG. 19 illustrates a Data Entry Preferences screen that can be used tosave time in manually entering data by setting up Data EntryPreferences. For example, if a user regularly takes a certain type ofinsulin at a particular dose, the user can enter it here. The same istrue for regular exercise routines and other medications the user maytake. Information entered here will then be automatically listed whenmanual entries are made. To enter your preferences, the user selects aData Entry Preferences tab and fills in Exercise Preferences (type,duration, intensity); Insulin Preferences (insulin name, dosage, type);and/or Medication Preferences (medication name, dosage, number ofpills). Each column heading preferably has a drop-down box. A user canselect one of the listed entries or type in a new entry that will beadded to the list.

A user may select a Glucose Targets tab to enter target glucose ranges.If these are not known, the HCP can be contacted to help manage glucoselevels. The target ranges that are set are displayed on a graph on thescreen illustrated at FIG. 20, as well as in many other reports that canbe generated by the System. The ranges may be displayed in signal colorsfor easy viewing.

A graph can be viewed preferably in at least three modes. A desired modemay be selected from a Mode drop-down box 40, such as that illustratedat FIG. 21. Standard, Pre/Post Meal and All Time Periods modes may beselected. In Standard mode, glucose target ranges set apply to allglucose readings, regardless of when the glucose reading is taken. Forexample, target ranges will be the same for pre-meal readings as forpost-meal readings or bedtime readings. In Pre/Post Meal mode, glucosetarget ranges set for pre-meal readings can be different from the targetranges for post-meal readings. In All Time Periods mode, glucose targetranges set can be different for each time period listed, for example,Pre-Bkfst, Post-Bkfst, Pre-Lunch, Post-Lunch, Pre-Dinner, Post-Dinner,Bed, and Sleep. FIG. 22 illustrates Ore/Post Meal Mode with Hypo/Hyperchecked (left) and All Time Periods Mode (right).

Glucose targets may be set in all three modes to take advantage ofdifferent reports the System can create. A table of the reports that useglucose targets and the modes they use is provided further below. Theglucose targets mode selected here will become the default and willdisplay in the reports that use glucose targets. To change the mode, adifferent Mode can be selected by returning to the Glucose Targetsscreen illustrated at FIG. 21.

Clicking on up/down arrows for High and Low sets glucose targets. Toautomatically restore Glucose Target Ranges to the ranges shown in FIG.20 (the defaults), a Restore Default Glucose Target Ranges button 42 canbe clicked. Clicking Restore Default Glucose Target Ranges 42 preferablyautomatically also restores the mode to Standard Mode and unchecks a UseHypo/Hyper Values box 44 illustrated at FIG. 23. Checking the UseHypo/Hyper Values box 44 activates Very Low and Very High data fields 46and 48. Clicking on up/down arrows for Very Low 46 and Very High 48changes these values.

To customize Time Periods to a normal daily schedule, a user can clickon up/down arrows next to a time period (for example, Pre-Bkfst,Post-Bkfst, Sleep, etc.) to change the time. To automatically restoreall Time Periods to the times shown here as defaults, a user can clickRestore Default Time Periods in the box illustrated at FIG. 24. TheSystem will generally not allow a user to enter a normal daily schedulethat exceeds 24 hours. If a user tries, he or she will receive an errormessage illustrated at FIG. 25, and the time periods will be readjustedto equal 24 hours. As user can select a Glucose Unit of Measure from thedrop-down box illustrated at FIG. 26. The default is mg/dL; and anotherchoice is mmol/L.

An option tab may be selected, and an options screen will appear such asthat illustrated at FIG. 27. Under Program Options, boxes may be checkedfor the options a user wishes to use. A user may also select Data Entryand Report Options, and can select the options that apply to his or herdiabetes management. This simplifies use, entry, and viewing ofdata/events.

By selecting Rights 52 at the lower left of the Options screenillustrated at FIG. 27, a User Rights screen displays as illustrated atFIG. 28. A user may choose to control access for additional profilesthat he or she may create. By checking the Edit Data box 54 allows theuser to edit data/events and delete user accounts. For example, manyhouseholds might have only one person using the System, but somehouseholds may have more than one.

Home User: Managing a User Profile

A user profile may be changed or updated. A user selects the tab he orshe wants (e.g., User Information, Health Profile, etc.) and changes oradds information.

A User Profile may also be added by selecting Add User from a Filedrop-down box on the Home Page. FIG. 29 illustrates a File Drop-Down Boxfor Adding a User.

A user may also remove a User Profile at a User List screen such as thatillustrated at FIG. 30. If a user tries to delete his or her own userprofile, the System will display an error message such as thatillustrated at FIG. 31.

User rights may also be assigned. From the UserProfile drop-down box onthe main menu bar 2 of the Home Page, User List may be selected asillustrated at FIG. 32. The User List screen displays (see FIG. 30).User rights may be changed by first highlighting the name of the userwhose rights are to be changed. The User Rights screen will appear suchas illustrated at FIG. 33, and rights can be selected or de-selected bychecking or unchecking appropriate boxes. The Edit Data box 54 allowsthe user to edit data/events and/or delete user accounts.

A HCP Profile may also be added. A user can create as many HCP profilesas is desired. This is often a good way to store names, addresses, andother information about doctors, clinics, etc. The HCPs added here willnot have access to the user's System data unless the user invites themto share your data (described below). FIG. 34 illustrates a drop downbox for adding a HCP. The Profile for screen displays as illustrated atFIG. 35. A user may select a description of the HCP from the HCP Typedrop-down box illustrated at FIG. 36. If there is no selection for theone desired, then a user may type in a description.

A HCP Profile may be edited. From the UserProfile drop-down boxillustrated at FIG. 37, which is accessible from the main menu bar 2 ofthe Home Page, HCP List is selected and the HCP list screen appears (seeFIG. 38). The name of the HCP User is then highlighted. By selectingEdit HCP Profile from the File menu on the HCP List screen, or clickinga representative icon, the Profile for screen for the HCP user displays,and edits can be made on the screen.

A HCP Profile can be removed. From the UserProfile drop-down box on themain menu bar (see FIG. 37), a user can choose HCP List. By highlightingthe name of the HCP User on the HCP List screen, and selecting RemoveHCP from the File menu on the HCP List screen, the HCP can be removed.The System will ask the user to confirm.

HCP User: Setting Up a User Profile

With a User ID and password, a user can use the System. But to takegreater advantage of the System, a user may also set up a HCP Profile.This will allow a HCP user to view (and sometimes edit) data and reportsto monitor trends in the patient's health or care. FIG. 39 illustrates aHCP Home Page. On the Home page, a user may select HCP Profile from theUserProfile drop-down box 64 on the main menu bar 62. The HCP Profilefor screen displays with the User Information tab selected asillustrated at FIG. 41. Information is filled in here. Information maybe added by selecting items from drop-down boxes or by keying in wordsand numbers. If a desired HCP type is not found in the HCP Typedrop-down box, a description can be entered at the keyboard.

Glucose Targets

The Glucose Targets tab 66 can be selected from the HCP profile forscreen illustrated at FIG. 42 to customize glucose target ranges. Theglucose targets set here will apply to the reports viewed for thepersons with diabetes the HCP user manages via the System. A HCP usermay view the graph in three modes as illustrated in FIG. 43 by selectingthe desired mode from the Mode drop-down box. The standard, Pre/PostMeal and All Time Periods modes were described above and not repeatedhere. In addition, setting target glucose ranges were described aboveand the descriptions of FIGS. 44, 45 and 46 are similar to thosedescribed above and thus not repeated here. FIGS. 47-48 illustrate anOptions tab and User Rights screen also similar to described above fordiabetic users and not repeated here. In addition, managing a HCPprofile is similar to managing a diabetic user profile, and thatdescription is not repeated here with reference to FIGS. 49-54.

A user may set an Authorization Level (, e.g., None, Read Only, Full,Owner) for the HCP by checking the desired level as illustrated at FIG.55. Adding, Editing and Removing HCP profiles are similar to thosedescribed above and not repeated here with reference to FIGS. 55-57.However, if a HCP is to be removed, and if local patients are assignedto this HCP, the System then will prompt the user to reassign thepatients to another HCP on the local computer as illustrated at FIG. 58.User rights may be assigned similar to above at a User Rights screen asillustrated at FIG. 59.

Data Entry

There are three ways to enter events (data) into the System inaccordance with a preferred embodiment: upload from a device, manuallyenter data (e.g., from a keyboard, and import an existing file ordatabase. The System can upload data from supported glucose monitoringdevices (meters), such as FreeStyle Meter, Precision Xtra Meter,FreeStyle Flash Meter, FreeStyle Tracker System, and glucose meters ofcompanies other than Abbott Diabetes Care™, as well as insulin pumps. Atleast the following data (event types) may be automatically uploaded tothe System when uploading from a device: glucose readings, state ofhealth, insulin doses, lab results, carbohydrates, medical exams,exercise, ketones (blood), medications and notes. Data previouslyuploaded from a device will not be overwritten when uploading again fromthat same device. Only the new data will be uploaded to your file. Meterfunctions, displays, and printed output assume a single glucosecalibration type, either plasma or whole blood. When uploading glucosedata from a device, the System does not differentiate between devicesthat are whole-blood or plasma calibrated. The System merely uploads thedata with no calculations made. Because there are slight differencesbetween the two calibrations, a user should not mix data from devicesthat use different calibration references. Uploading data into a user'saccount occurs if the device contains only that person's data. TheSystem is preferably designed not to upload a specific portion of datafrom a device if data is intermixed with data from another person.

Connecting a Device to a Computer

Before uploading, the device is connected to an available COM port on aPC or other computing appliance using an approved data cable for thatdevice. A exemplary cable connection is illustrated at FIG. 60. To setup the device to the computing device, on the Home page, the user whosedata is being uploaded from the device is selected, from the select usermenu illustrated at the Home page of FIG. 61. Next, Data Entry 72 isselected on the main menu bar 2, as illustrated at FIG. 62; and thenDevice Setup 74 is chosen from the drop-down list.

A Device Setup screen appears as illustrated at FIG. 63. Under SelectOptions 76, the device is selected from the Meter Type drop-down list78. The communications port (COM1, COM2, etc.) is selected from theAvailable Ports drop-down list 80. The System stores Meter Type andAvailable Ports settings during Device Setup. The user will not have toselect them the next time he or she uploads data from this meter as longas he or she connects the device to the same communications port. Byclicking Test at the bottom of the Device Setup screen illustrated atFIG. 63, the device details are displayed in the Details box 84, and theSystem is ready to upload data from the meter. An illustration of themeter and details are preferably displayed as illustrated at FIG. 64.

Uploading Data from a Device

Once the device is connected to the computer and the device is set up,data may be uploaded to the System. On the home page the user whose datais being uploaded from the device is selected. As illustrated at FIG.65, from DataEntry on the main menu bar; Read Device 86 is selected fromthe drop-down list. When a device has been detected but cannot beidentified as belonging to a specific user, the System will prompt theuser to assign the device to an existing user or to add a new user asillustrated at FIG. 66. The data from the device is then automaticallyuploaded to the PC. A progress bar indicates when the upload iscomplete. A summary of the upload then displays in a pop-up window asillustrated at FIG. 67.

A device upload may be undone. That is, the data from the most recentdevice upload may be undone as long as no data has been manually sincethe device upload and another user has not been selected. DataEntry isselected on the main menu bar of the Home page; then Undo Last Upload 88is chosen from the drop-down menu illustrated at FIG. 68. The Systemwill then automatically undo the last upload.

Uploading from a PDA-based system such as the FreeStyle Tracker Systemmay be handled somewhat differently than uploads from other devices asfollows. The PDA-based system is connected to the PC. DataEntry isselected from the main menu bar, and Read Tracker 90 or other PDA-basedproduct is selected from the drop-down list as illustrated at FIG. 69.If the device is detected, the System prompts to HotSync 92 asillustrated at FIG. 70. As HotSync takes place, the HotSync Progressscreen displays as illustrated at FIG. 71.

When HotSync completes, options may be selected for upload from theFreeStyle Tracker of other PDA-based device such as Event Data, GlucoseTargets, Time Periods and Preferences, as illustrated at FIG. 70. EventData will be generally automcatically uploaded from the FreeStyleTracker System. Glucose Targets may be selected to upload and overwritethe Glucose Targets data with data from the FreeStyle Tracker System.Time Periods may be selected to reset Time Periods data according todata from the FreeStyle Tracker System. Preferences may be selected tooverwrite Preference Settings with settings from the FreeStyle TrackerSystem. Set as Default may be selected if a user wants to save theseoptions as the defaults. If prompted to assign the device to a currentuser or to a new user, as illustrated at FIG. 72, then OK should beclicked after making a choice, keeping in mind that more than one devicemay be associated with a same user.

As data from the FreeStyle Tracker System is uploaded, the Systemdisplays the Profile Updated message illustrated at FIG. 73 ifPreferences were checked on the Read Tracker screen of FIG. 70. When theupload is done, an Upload Summary screen displays (see FIG. 74). Itshows a list of the type and number of events uploaded.

Manual Data Entry

The System allows data to be added, edited, deleted, and recoveredmanually, e.g., from a keyboard. When manually recorded events aredeleted, they are omitted from views and reports but are preferably notremoved from your database. A complete list of a user's events (whetherentered manually, uploaded, or imported) may be viewed by clicking onReports 94 and selecting Diary List 96 as illustrated at FIG. 75.

Manually recordable events include the following categories: glucosereadings, glucose control readings, insulin doses, meals (carbohydratesin grams, e.g.), exercise sessions, state of health/health conditions,medication doses, medical exams, lab results, ketone readings, or ketonecontrol readings, or combinations thereof.

FIG. 76 illustrates a glucose reading data entry screen. If the date andtime of the glucose reading are different from the current date andtime, the Date, Time, and Time Period fields 98 at the top of theGlucose Reading screen should be adjusted using drop-down boxes andup/down arrows. The value of the manual glucose reading should beentered in the Glucose Value field 100. In the Sample Site field 102,the site may be selected from which the reading was taken (finger,forearm, etc.). In the Hours Since Last Meal field 104, the time of thelast meal should be entered. A calibration code may be entered from theglucose monitor into the Calibration Code field 106. The control readingbox 108 should be checked if this is a Control Solution reading fromyour glucose monitor. To add another event, the icon at the top of theData Entry screen should be selected that applies, e.g., Insulin, Meal,Exercise, Health, Meds, Exam, Lab, Ketones, or Note.

Recording an Insulin Dose

The insulin data screen illustrated at FIG. 77 will display when theinsulin icon 110 is clicked on the Data Entry screen. An icon may beclicked at the Home page to get to the data entry screen as alreadydescribed. The Date, Time, and Time Period fields can be set using theup/down arrows for the time of the injection that is being recorded. Thefield 112 directly under the Insulin Name header is for selecting thebrand of insulin from the drop-down box. If the name of the insulin isnot listed, it can be typed in. Dosage (Units) and injection type alsoare entered. Injection types generally include bolus, injection, meal,correction, combination, dual wave, and square wave.

Recording a Meal

A meal may be recorded by selecting the Meal icon from the Data Entryscreen to reveal a Meal data entry screen as illustrated at FIG. 78.Date, Time, and Meal fields may be adjusted for the meal being entered.Drop-down boxes may be used to describe the meal. The drop-down boxdisplays a very extensive list of foods to choose from. If what waseaten is not listed, it may be typed in. Serving size and carbohydratesper serving should be entered with it. The number of servings should beselected, after which the grams of carbohydrates per serving and totalcarbs are automatically displayed.

One meal may include more than one item (beverage, entree, fruit, etc.).To select several items to describe one meal, a food is selected in theFood Item list as well as the number of servings eaten. The Carbs andTotal Carbs automatically display. The cursor is placed in the TotalCarbs field to the right of the carbs displayed there. Then, anotheritem is selected and so on. As items are added, the total carbs for themeal are shown as illustrated at FIG. 79. Other activities may berecorded including Exercise Activity (FIG. 80), State of Health (FIG.81), a Medication event (FIG. 82), a Medical Exam (FIG. 83, a Lab TestResult (FIG. 84), a Ketone Reading (FIGS. 85 and 86) and notes (FIG.87).

To make manual data entry faster and easier, a user can modify severalof the drop-down lists by adding new entries or by hiding entries he orshe does not use. The following lists may be modified.

-   -   Exercise Types    -   Food Items    -   Insulin Names    -   Test Types    -   Medications    -   Exam Types

A list may be customized by selecting Customize Data Entry Lists 114from the DataEntry drop-down box as illustrated at FIG. 88. The desiredlist is selected from the Select List to Customize drop-down list 116illustrated at FIG. 89. FIGS. 90-95 illustrate different lists from theabove table that may be customized.

Importing a Database

Some databases can be imported directly into the System. Databases fromcertain programs may be automatically detected by the System as long asthe software for the programs that created them is installed on theuser's PC. These programs are referred to as supported databases. Toimport a database, DataEntry 118 is selected on the main menu bar 2 ofthe Home page; and then Import 120 is selected from the drop-down box.From the Import drop-down box 122, the name of the device to upload thedatabase from is selected as illustrated at FIG. 96. If the database isdetected, the System will simply ask the user to confirm the importoperation. If the database is not detected, the file browser opens asillustrated at FIG. 97. The user then browses to the directory where thefile is located, selects the file type in the Files of Type window 124,and ff the file is located in that directory, it will be displayed andcan be opened. FIG. 98 illustrates an Import Drop-Down Box forActivating FreeStyle CoPilot I Data, and FIG. 99 illustrates an ImportDrop-Down List for Importing Events From a File. FIG. 100 illustrates aFile Browser Window for selecting a file type for automatic importaccording to file type.

Exporting Data

Exporting data is similar to archiving data (see below), except thatexported data is not removed from the System's database. To export data,a user selects Reports 126 on the main menu bar; then chooses Diary List128 from the drop-down box, as illustrated at FIG. 101. The Diary Listdisplays, which is a log of the events that have been entered. The datemay be adjusted to include the data desired to be exported, asillustrated at FIG. 102. A user selects Export from the File menu on theHome page. When file browser opens, a user'can browse to the directorywhere the file is to be saved as illustrated at FIG. 103.

Reports

With the FreeStyle CoPilot System, data entered manually or uploadedfrom a device can be displayed on the screen in a variety of ways.Statistical and other calculations are automatically performed on thedata, and the results are put into tables and graphs. A report is one ora set of these tables and/or graphs designed to present informationhelpful for health management. A reports window is illustrated at FIG.104 as a Glucose Modal Day Report (Default Report).

A report can be customized to a user's preferences. Many variables canbe adjusted in real time as the report is studied. Data preferablycannot be changed in reports except the Diary List. Corrections oradditions can be made by accessing the Data Entry screen for the event.The changes display immediately on any affected report.

Once opened, a report remains open until it is closed by the user. Anynumber of reports can be open at the same time; while preferably onlyone is visible. Each open report shows as a tab at the top of thescreen. Open reports apply an active date range, data filter options,and display features. In a preferred embodiment, changing these settingsin one report changes them for one or more other open reports.

Opening a Report

To call up a default report from the Home page, the View Reports largebutton is clicked. The user may select a default report and date rangeinterval. To open another report, a name may be selected from adrop-down box under Reports on the main menu bar as illustrated at FIG.105. The first report remains open but hidden, except for its tab (seeFIG. 106). The new report displays with the same date range, active datafilters, and display features. To redisplay a report, the user clicksits tab. To close an active report, the user clicks the Close Reporticon on the Reports toolbar.

Navigating a Report

The reports screens offer numerous tools for navigation, including toolsfor setting the date range, interactive data elements, and signal colorsthat help users interpret reports at a glance. Displaying the legendwill help a user understand the report.

The data range may be adjusted to include any date and any date interval(see FIG. 107). To view entries over a date range ending on the currentdate (up to and including today's data), a user may select an intervalof interest (for example, Last 2 Weeks, Current Month, etc.) from anInterval drop-down box on the Reports toolbar.

To move back in time in increments equal to the currently displayed dateinterval, the user clicks the Previous arrow (For example, if a 2-weekdate range is currently displayed, the user clicks the Previous arrow todisplay additional 2-week intervals). To move forward in time, the usermay click the Next arrow. To select a specific date range (withbeginning and ending dates specified), the user clicks or otherwisechooses the respective dates from the drop-down calendars.

Data Elements

The reports preferably have interactive data elements that link torelated or more complete information. These elements can include datapoints on a graph, regions on a chart, and/or cells in a table. Apointer becomes the hand icon when it is hovering over an interactivedata element. For example, by hovering the pointer over a triangle(glucose reading data element), a user can display the value, date, andtime of the reading in a pop-up bubble. To go to the Glucose Readingevent in the Diary List, the user can double-click the triangle. Forexample, carbohydrate events are represented by peach-colored circles;the size of each circle is proportional to the carbohydrate value.Insulin data is represented by dark green and dark red bars. Glucosereadings are represented by circles (manual entries) or triangles(uploaded entries), which can be linked by a solid or dotted line.

Glucose readings are separated into target ranges, which are representedon graphs and tables either in signal colors or in distinctive patternsfor black-and-white printing. A user can choose to display data in threeranges (High, Within, and Low) or five ranges (Very High, High, Within,Low, and Very Low). These choices can be changed at any time on theMiscellaneous tab of the Report Configuration form (see FIG. 111) bychecking or unchecking the Show Hypo/Hyper box. Each target range isassociated with a distinctive signal color: Very High (turquoise), High(purple), Within (green), Low (peachy-gold), and Very Low (pink). If auser selects to display glucose data in three ranges (the ShowHypo/Hyper box is not checked), Very High readings display as Highreadings (purple) and Very Low readings display as Low readings(peachy-gold).

Reports may be printed (using a Print drop down box such as thatillustrated at FIG. 108) and sent using standardized printing and emailor fax architectures. A user may print one copy of each of his or herfavorite reports on a default printer by clicking Print FavoriteReports. To save the open report in the Adobe Acrobat (PDF) file format,a user can click Save as PDF file. A user can select this option if theE-Mail Report to option (below) does not automatically create a *.pdffile. A user can select this option if there is a printing problem andthen the report may be printed from Adobe Acrobat. To email a report asan attachment, a user can click E-Mail Report to, and the report will beattached to the e-mail message as a *.pdf file. (The user does not haveto Save as PDF file before selecting E-Mail Report to). The E-MailReport option is designed to automatically access a user's e-mailaccount and open a new e-mail message screen. The report isautomatically attached to the message as a *.pdf file. If the e-mailaccount is not detected automatically, the user may e-mail the reportmanually.

Reports can be personalized to a user's preferences by making choicesfor Report Options on the Profile for screen and by activating datafilters and display features on the Report Configuration screen. FIG.109 illustrates a User Profile Screen with Options Tab Active. Reportoptions include default report type, default report data range, includestatistics summary with each report printout, Print Favorite ReportsAfter Device Upload, and Favorite Reports.

Data filters are tools for selecting the types of data a user wants toinclude in a report. A user selects the data filters desired by clickinga Report Configuration icon on the Reports toolbar and choosing itemsfrom the Event Types, Time Periods, and Week Days sections on the DataFilter tab (see FIG. 110). Data filters and display features (see below)preferably apply to all reports except the HCP Group Analysis Report.Changing data filter or display settings in a report changes them forother open reports. Not all filters are configurable in all reports.Several data filters can be applied together. For example, a user coulduncheck Exercise events in the Event Types filter and check only Tuesdayand Friday in the Week Days filter.

Some display features are configured on the Miscellaneous tab of theReport Configuration screen, as illustrated at FIG. 111. These includeoptions to display time periods, show hypo/hyper, show glucose targets,show hidden data, show text on graphs in daily combination report, showlegend and color. FIG. 112 illustrates a black-and-white display havingdistinctive patterns (screen detail).

Glucose Target Modes

The following is a table of reports that use glucose targets and themodes they use.

Reports: Glucose Target Modes Used Home Version HCP Version ReportGlucose Target Mode Glucose Target Mode Diary List User's choice HCP'schoice Glucose Modal Day User's choice HCP's choice Glucose LineStandard Mode Standard Mode Glucose Average Standard Mode Standard ModeGlucose Histogram Standard Mode Standard Mode Glucose Pie User's choiceHCP's choice Logbook User's choice HCP's choice Lab & Exam Record Notapplicable Not applicable Statistics User's choice HCP's choice DailyCombination View User's choice HCP's choice Weekly Pump View StandardMode Standard Mode HCP Group Analysis Not applicable Standard Mode

Definition of a Day

Depending on the report, a day (24 hours) is calculated from midnight tomidnight or pre-breakfast to pre-breakfast. The various reports define aday as follows:

REPORTS: DEFINITION OF A DAY Report Definition of a Day Diary ListMidnight to Midnight Glucose Modal Day Pre-breakfast to Pre-breakfastGlucose Line Midnight to Midnight Glucose Average Pre-breakfast toPre-breakfast Glucose Histogram Midnight to Midnight Glucose Pie - TotalPie Pre-breakfast to Pre-breakfast Logbook Pre-breakfast toPre-breakfast Lab & Exam Record Midnight to Midnight StatisticsPre-breakfast to Pre-breakfast Daily Combination View Midnight toMidnight Weekly Pump View Midnight to Midnight HCP Group AnalysisMidnight to Midnight

Descriptions of Reports

The Diary List is a table of data entries made over the specified daterange. Each row corresponds to one event. FIG. 113 illustrates a DiaryList. A day (24 hours) is defined as midnight to midnight. The glucosetarget mode is user's choice. Columns are for data categories. The Valuecolumn displays the value in units appropriate to the event type. ForGlucose Reading events, the Value cell is shaded with the signal colorfor the glucose target range. To call up the original Data Entry screenfor a specific event, the user can double-click any cell in the row.Data that was entered manually can be edited. Uploads from devicescannot be edited.

To Hide an event, a user can click any cell in the row, thenright-click, and then Click Hide Data on the pop-up menu (see FIG. 114).To Un-Hide the event, the user can click on the Reports toolbar. On theMiscellaneous tab screen, the user can check the box to Show HiddenData. The Diary List now displays with a Hidden column (far left).Hidden entries display in this column. The user can Right-click thehidden entry and select Un-Hide Data. The event is no longer hidden.

A user can customize columns in the Diary List by changing the order ofevents in a column, adding and removing columns, and resizing columns.To change the order of the events in the Diary List, the user can clickany of the following column heads:

Hidden Hidden entries display at the top. Click to display hiddenentries at the bottom. Type Events are grouped by Event Type. Click toreverse the order. Date Events display in ascending order (earliest dateat the top) or descending order (latest date at the top). Click toreverse the order. Time The events display in chronological order. Clickto group entries by time of day. Time Period Time periods are arrangedin chronological order. Click to list the time periods in alphabeticalorder. Value Click to change the order. Description Events are displayedin ascending alphabetical order. Click to reverse the order. Other InfoClick to reverse the order. Comment Events with Comments display inascending alphabetical order. Events with no comments display first.Click to reverse the order.

To remove a column from the report, the user can drag-and-drop thecolumn head cell off the table. To add a column to the report,right-click anywhere on the table to call up the pop-up window (see FIG.114). Select Customize Columns. The Customization list displays (seeFIG. 115). From the list, select the column head you want to add. Thendrag-and-drop it to the preferred position in the column-head row. Twogreen arrows display to help you position the column. To move columnsleft or right in the table, the user can drag-and-drop the column-headcell to the preferred position in the column head row. To adjust thewidth of any column, the user can use the sizing tool that becomesactive when hovering the pointer over the right margin of thecolumn-head cell.

Glucose Modal Day Report

The Glucose Modal Day Report shows the daily pattern of glucose levelsover the specified date range. A dotted line linking the readings for aspecific date can be displayed or hidden. FIG. 116 illustrates a GlucoseModal Day Report (Dotted Line Linking Readings for Apr. 3, 2004). Thehorizontal axis is a 24-hour timeline. All readings for all datesdisplay on the same timeline. The vertical axis plots the glucose level.A day (24 hours) is defined as pre-breakfast to pre-breakfast. Theglucose target mode is user's choice. Each data element represents oneglucose reading. For the date, time, and value of the reading, thepointer can be hovered over the triangle. HI/LO indicates a readingoutside the working range of the meter. A list of all days in the daterange displays to the right of the graph. To link all the readings for asingle day with a dotted line, the user can click the date of interestin the list of all days in the date range (FIG. 116). All the dataelements for that date change color and enlarge, and a dotted line isdrawn linking them. By clicking on it, a triangle data element in theline can be cancelled.

To zoom in on (magnify) an area of the graph, a user can place the mousein the upper left of the graph, press and hold the left mouse button,and drag to the lower right corner of the graph. The user can repeatthis action to further magnify the area of interest. To return the graphto its original state, the user can place the mouse in the lower rightof the graph, press and hold the left mouse button, and drag to theupper left corner. To go to the Glucose Reading entry in the Diary List,the user can double-click the data element.

Glucose Line Report

The Glucose Line Report is useful for seeing trends in glucose levels.It plots each glucose reading over the specified date range. FIG. 117illustrates a Glucose Line Report (Show Line Is Activated). Thehorizontal axis is a timeline of the entire date range. The verticalaxis plots the glucose level. A day (24 hours) is defined as midnight tomidnight. The glucose target mode is Standard. Each data elementrepresents one reading; a solid line connecting them can be displayed orhidden. To hide the line, point to any data element, then right-click. Auser can click Show/Hide Line on the pop-up menu (see FIG. 118). For thedate, time, and value of the glucose reading, the pointer can be hoveredover the data element. To zoom in on (magnify) an area of the graph, theuser can place the mouse in the upper left of the graph, press and holdthe left mouse button, and drag to the lower right corner of the graph.The user can repeat this action to further magnify the area of interest.To return the graph to its original state, the user can place the mousein the lower right of the graph, press and hold the left mouse button,and drag to the upper left corner. To go to the event data in the DiaryList, the user can double-click the data element.

Glucose Average Report

The Glucose Average Report may help identify times of the day that mayneed more testing or improved control. The report separates glucosereadings over the specified date range into pre-meal (cream-coloredbars) and post-meal (blue bars) groupings and averages the values foreach group. For convenience, there are two graphs. One shows pre-mealand post-meal glucose averages over the date range by meal. The othershows overall pre-meal and post-meal averages by day over the daterange. FIGS. 119-120 illustrate Glucose Average Reports by meal and byday, respectively. The horizontal axis is a timeline showing the timeperiods (pre-meal and post-meal) and the average for all meals. Thevertical axis plots the glucose level. Each bar shows the average valueof all glucose readings over the date range for the specific time period(for example, the average value of all pre-breakfast readings). A day(24 hours) is defined as pre-breakfast to pre-breakfast. A user canDouble-click any bar to call up the Diary List entries for these events.

Glucose Histogram Report

The Glucose Histogram Report separates glucose readings over thespecified date range into the default target ranges and displays thedata as a histogram (bar chart) with its bar height proportional to thenumber of readings in each glucose target range. FIG. 121 illustrates aGlucose Histogram Report. The horizontal axis shows the default glucosetarget ranges (not the user-defined glucose target ranges). The verticalaxis plots the glucose level. A day (24 hours) is defined as midnight tomidnight. The color of the bar corresponds to the signal color for theglucose target range. The height of the bar is proportional to thenumber of readings in that range; that is, the bar for a range in whichthere are 20 readings is twice as high as the bar for a range with 10readings. The percentage of readings in the range is shown at the top ofthe bar. The user can double-click the bar to call up the Diary Listentries that make up that bar.

Glucose Pie Chart

The Glucose Pie Chart separates glucose readings over the date rangeinto the default glucose target ranges and averages the values withineach range. These averages are displayed in a series of pie charts. Eachsegment (wedge) displays in the signal color of its glucose targetrange. FIG. 122 illustrates a Glucose Pie Chart Report: Total ReadingsPie Chart, and FIG. 123 illustrates a Glucose Pie Chart Report: TenSummary Pie Charts. A maximum of 10 individual pie charts (2 rows of 5)and 1 total pie chart summarizing the glucose readings for allconfigured time periods over the date range are displayed. A day (24hours) is defined as pre-breakfast to pre-breakfast on Total Readingspie chart (see FIG. 122). The glucose target mode is user's choice. Auser can double-click a wedge on any of the pie charts to call up theDiary List entries that make up that wedge.

Logbook Report

The Logbook Report is a table of glucose, carbohydrate, and insulinvalues associated with each time period over the specified date range.FIG. 124 illustrates a Logbook Report. Insulin, carbohydrate, andpre-meal, post-meal, bedtime, and sleep glucose reading values aredisplayed in columns under each time period (Breakfast, Lunch, Dinner,Bed and Sleep) for each day over the date range. A day (24 hours) isdefined as pre-breakfast to pre-breakfast. The glucose target mode isuser's choice. To call up the entry in the Diary List, a user candouble-click any cell in the row.

Lab and Exam Record Report

The Lab and Exam Record Report is a table of data from all Medical Examand Lab Test Result data entry screens over the specified date range.FIGS. 125-127 illustrate Lab & Exam Record Reports: Lab Record, ExamRecord, and A1C History, respectively. The screen shows a table of labtest data on the top (FIG. 125) and the exam data below (FIG. 126). Eachevent is shown in one row. Below the table is a graph showing A1C testresults for the current year and the previous year (FIG. 127). A day (24hours) is defined as midnight to midnight. A user can double-click anycell in a row to go to the Diary List entry for the event. The user candouble-click any bar on the graph to go to the Diary List entry for theA1C test event.

Statistics Report

The Statistics Report provides an overview of glucose, carbohydrate, andinsulin data (including insulin pump data) over the date range anddisplays it in a series of tables. A user can attach the StatisticsReport to any other report by default. FIG. 128 illustrates a StatisticsReport: Glucose Statistics. A day (24 hours) is defined as pre-breakfastto pre-breakfast. The glucose target mode is user's choice. A user candouble-click any cell to see the entries from the Diary List that areincluded in the data set for a particular statistical calculation.

Glucose Statistics

The Glucose Statistics table (see FIG. 128) shows data regarding thenumber of readings per day, the values of the highest and lowestreadings in each time period, and the results of some automaticcalculations (averages and standard deviation) within and across timeperiods.

# Readings By Time Period: Reports the number of readings recordedduring the Time Period specified for each day of the selected DateRange. Total/Summary: Reports the number of readings recorded during theselected Date Range. # Days w/ By Time Period: Reports the number ofdays within the selected Readings Date Range where one or more readingsare recorded during the specified Time Period. Total/Summary: Reportsthe number of days within the selected Date Range where one or morereadings are recorded. Avg Readings/ By Time Period: Reports the numberof readings recorded during Day the Time Period specified for each dayof the selected Date Range divided by the number of days in the selectedDate Range regardless of whether a glucose reading was recorded or not.Total/Summary: Reports the number of readings recorded during theselected Date Range divided by the number of days in the selected DateRange regardless of whether a glucose reading was recorded or not.Highest By Time Period: Reports the highest reading recorded during theTime Period specified within the selected Date Range. Total/Summary:Reports the highest reading recorded during the selected Date Range.Lowest By Time Period: Reports the lowest reading recorded during theTime Period specified within the selected Date Range. Total/Summary:Reports the lowest reading recorded during the selected Date Range.Average By Time Period: Reports the sum of the readings recorded duringthe selected Date Range that fall within the specified Time Perioddivided by the number of readings recorded during the selected DateRange that fall within the specified Time Period. Total/Summary: Reportsthe sum of the readings recorded during the selected Date Range dividedby the number of readings recorded during the selected Date Range.Standard By Time Period: Reports the mean* of the readings recordedduring Deviation the Time Period specified within the selected DateRange. Total/Summary: Reports the mean* of the readings recorded duringthe selected Date Range. Note: N/A is displayed where fewer than threereadings are recorded. Above % By Time Period: Reports the number ofreadings recorded above the patient's defined normal glucose limitsduring the Time Period specified within the selected Date Range dividedby the total number of readings recorded during the Time Periodspecified within the selected Date Range.** Total/Summary: Reports thetotal number of readings recorded above the patient's defined normalglucose limits during the selected Date Range divided by the totalnumber of readings recorded during the selected Date Range.** Within %By Time Period: Reports the number of readings recorded within thepatient's defined normal glucose limits during the Time Period specifiedwithin the selected Date Range divided by the total number of readingsrecorded during the Time Period specified within the selected DateRange. Total/Summary: Reports the total number of readings recordedwithin the patient's defined normal glucose limits during the selectedDate Range divided by the total number of readings recorded during theselected Date Range. Below % By Time Period: Reports the number ofreadings recorded below the patient's defined normal glucose limitsduring the Time Period specified within the selected Date Range dividedby the total number of readings recorded during the Time Periodspecified within the selected Date Range.** Total/Summary: Reports thetotal number of readings recorded below the patient's defined normalglucose limits during the selected Date Range divided by the totalnumber of readings recorded during the selected Date Range.** Very High% By Time Period: Reports the number of readings recorded as hyperevents during the Time Period specified within the selected Date Rangedivided by the total number of readings recorded during the Time Periodspecified within the selected Date Range.*** Total/Summary: Reports thetotal number of readings recorded as hyper events during the selectedDate Range divided by the total number of readings recorded during theselected Date Range.*** High % By Time Period: Reports the number ofreadings recorded above the patient's defined normal glucose limits andbelow the limits of a hyper event during the Time Period specifiedwithin the selected Date Range divided by the total number of readingsrecorded during the Time Period specified within the selected DateRange.*** Total/Summary: Reports the total number of readings recordedabove the patient's defined normal glucose limits and below the limitsof a hyper event during the selected Date Range divided by the totalnumber of readings recorded during the selected Date Range.*** Low % ByTime Period: Reports the number of readings recorded below the patient'sdefined normal glucose limits and above the limits of a hypo eventduring the Time Period specified within the selected Date Range dividedby the total number of readings recorded during the Time Periodspecified within the selected Date Range.*** Total/Summary: Reports thetotal number of readings recorded below the patient's defined normalglucose limits and above the limits of a hypo event during the selectedDate Range divided by the total number of readings recorded during theselected Date Range.*** Very Low % By Time Period: Reports the number ofreadings recorded as hypo events during the Time Period specified withinthe selected Date Range divided by the total number of readings recordedduring the Time Period specified within the selected Date Range.***Total/Summary: Reports the total number of readings recorded as hypoevents during the selected Date Range divided by the total number ofreadings recorded during the selected Date Range.*** *The mean of therecorded readings is related to the patient's average glucose level. Forexample, a small number (less than half the average) indicates that mostof the glucose readings during the day are close to the average valueand that the patient is maintaining glucose levels near that value. Alarge number (more than half the average) indicates that many glucoselevels during the day vary considerably from the average and that thepatient is not maintaining glucose levels near the average value.**Available when three target zones are being reported: Show Hypo/Hypernot selected ***Available when five target zones are being reported:Show Hypo/Hyper selected.

Insulin Statistics

The Insulin Statistics table (see FIG. 129) shows average insulindosages over the date range (calculated from insulin data). FIG. 129illustrates a Statistics Report: Insulin and Carbs Statistics Tables.

Avg per Day By Time Period: Reports the sum of the units of Insulindelivered (insulin name) during the Time Period specified for theselected Date Range divided by the number of days in the selected DateRange where that particular type of Insulin was recorded during thatTime Period. Total/Summary: Reports the sum of the units of Insulindelivered during the selected Date Range divided by the number of daysin the selected Date Range where that particular type of Insulin wasrecorded. Note: Separate entries exist for each type of Insulinrecorded. Avg Total Insulin By Time Period: Reports the sum of the unitsof all Insulin delivered per Day during the Time Period specified forthe selected Date Range divided by the number of days in the selectedDate Range where any type of Insulin was recorded during that TimePeriod. Total/Summary: Reports the sum of the units of all Insulindelivered during the selected Date Range divided by the number of daysin the selected Date Range where any type of Insulin was recorded.

These entries are calculated using all types of insulin recorded.

Pump Statistics

If the insulin is administered by pump, the table (FIG. 129) will sayPump Statistics (instead of Insulin Statistics) and display thefollowing information:

Avg General By Time Period: Reports the sum of all Meal Bolus* InsulinBolus per Day recorded during the specified Time Period for the selectedDate Range divided by the number of days in the selected Date Rangewhere Meal Bolus* Insulin entries were recorded during that Time Period.Total/Summary: Reports the sum of all Meal Bolus* Insulin recordedduring the selected Date Range divided by the number of days in theselected Date Range where Meal Bolus* Insulin entries were recorded. AvgCorrection By Time Period: Reports the sum of all Correction BolusInsulin Bolus per Day recorded during the specified Time Period for theselected Date Range divided by the number of days in the selected DateRange where Correction Bolus Insulin entries were recorded during thatTime Period. Total/Summary: Reports the sum of all Correction BolusInsulin recorded during the selected Date Range divided by the number ofdays in the selected Date Range where Correction Bolus Insulin entrieswere recorded. Total Avg Bolus By Time Period: Reports the sum of allMeal and Correction Bolus per Day Insulin entries recorded during thespecified Time Period for the selected Date Range divided by the numberof days in the selected Date Range where Meal and Correction BolusInsulin entries were recorded during that Time Period. Total/Summary:Reports the sum of all Meal and Correction Bolus Insulin entriesrecorded during the selected Date Range divided by the number of days inthe selected Date Range where Meal and Correction Bolus Insulin entrieswere recorded. Avg Basal per By Time Period: Reports the sum of theBasal Insulin delivered Day during the Time Period specified for theselected Date Range divided by the number of days in the selected DateRange where Basal Insulin was recorded for that Time Period.Total/Summary: Reports the sum of the Basal Insulin delivered during theselected Date Range divided by the number of days in the selected DateRange where Basal Insulin was recorded. Avg Total Insulin By TimePeriod: Reports the sum of the Total Bolus and Basal per Day Insulindoses delivered during the Time Period specified for the selected DateRange divided by the number of days in the selected Date Range whereInsulin entries were recorded for that Time Period. Total/Summary:Reports the sum of the Total Bolus and Basal Insulin doses deliveredduring the selected Date Range divided by the number of days in theselected Date Range where Insulin entries were recorded. *Meal Bolus isdefined as the sum of all insulin entries (from pump uploads and manualentries) of the following injection types: Injection, Bolus, Meal Bolus,Combination Bolus, Dual Wave Bolus, and Square Wave Bolus.

Carbohydrate Statistics

The Carbs Statistics table (see FIG. 129) shows average carbohydratesover the date range (calculated from carbohydrates data).

Average per Day By Time Period: Reports the sum of the meal Carbohydrateintake Carbs for the Time Period specified during the selected DateRange divided by the number of days within the selected Date Range wheremeal Carbohydrate entries were recorded during the Time Periodspecified. Total/Summary: Reports the sum of the meal Carbohydrateintake during the selected Date Range divided by the number of dayswithin the selected Date Range where meal Carbohydrate entries wererecorded.

Daily Combination View Report

The Daily Combination View Report summarizes glucose, carbohydrate, andinsulin data (including pump data) for a single day and displays it inboth graphic and table formats. To select the day for the data you wantto see, a user can use the date field on the right (see FIG. 130). Also,the user can set the date field on the left to the same date. FIG. 130illustrates a Date Field for Selecting Date. FIG. 131 illustrates aDaily Combination View Report: Glucose Line and Carbohydrates Graphs.

Glucose Line Graph

This graph (see FIG. 131) plots glucose readings by hour of day. Thehorizontal axis is a 24-hour timeline. The vertical axis plots theglucose level. Each data element represents one reading. The user canHover the cursor over the data element to see the glucose value, date,and time of that reading. The user can double-click a data element toview this entry in the Diary List. To display or hide the solid lineconnecting the data elements, the user can right-click a data element,then select Toggle Glucose Line from the pop-up list.

Carbohydrates Graph

This graph (see FIG. 131) plots carbohydrate events by hour of day. Thecarbohydrate data element represents one carbohydrate event. The size ofthe circle is proportional to the carbohydrate value. Its position alongthe horizontal axis corresponds to the time (hour) of the meal. The usercan double-click an icon to view this entry in the Diary List.

Insulin Summary

FIG. 132 illustrates a Daily Combination View Report: Insulin Summaryand Data Table. This graph (FIG. 132) plots insulin events by hour ofday. The horizontal axis is a 24-hour timeline. The vertical axis isunits of insulin. Basal insulin data (light green shaded area) can beuploaded to the System. Each dark green bar represents one meal bolusinsulin event. Its position along the horizontal axis corresponds to thetime (hour) of the insulin event. Its height correlates with dosage. Auser can double-click to view this entry in the Diary List. Each red barrepresents one correction bolus insulin event. Its position along thehorizontal axis corresponds to the time (hour) of the insulin event. Itsheight correlates with dosage. A user can double-click to view thisentry in the Diary List. A meal bolus may be an extended, square wave,or combination bolus. The scale is indicated on the left.

Data Table

This table (see FIG. 132) tracks glucose, carbohydrates, and insulinvalues hourly. Each column represents 1 hour. Each event type is onerow. Each event is one cell. The value associated with the eventdisplays in the cell. A user can double-click the cell to view thisevent in the Diary List.

Weekly Pump View Report

The Weekly Pump View Report shows the components of insulin doses foreach day in a seven-day period in bar graph (FIG. 134) and pie chart(FIG. 135) formats. To select the week (7 days) for the data a userwants to view, using the date field on the right (see FIG. 133), theuser can select the last date in the week the user wants to see (Aug. 3,2004, for example). The user can set the date field on the left to thefirst day of that week (Jul. 28, 2004, for example). FIG. 133illustrates a Date Field for Selecting a Date. FIGS. 134-135 illustratesWeekly Pump View Reports: Bar Graph and Pie Charts and GlucoseStatistics Table, respectively. A Glucose Statistics table (see FIG.135) summarizes the glucose readings for the week displayed.

HCP Group Analysis Report

The HCP Group Analysis Report is available to HCP users only. Thisreport is a user-configurable view of all FreeStyle CoPilot System datafor all patients of the HCP. The HCP can display data for any patienthe/she manages. This includes all device data uploaded at the clinicduring a patient visit, all data entered manually at the clinic, and alldata imported into the HCP's database through information sharing (seeChapter 7, Host). This report facilitates viewing and comparing of datafor all patients of the HCP or clinic. FIG. 136 illustrates a HCP GroupAnalysis Report. By default, the report displays with column heads forPatient ID, Last Name, First Name, and for a number of event-relateddata fields. Data for each patient displays in one row. Each glucosevalue displays in a cell shaded the signal color of its target range.The glucose target mode is Standard. A day (24 hours) is defined asmidnight to midnight.

A user can customize the columns in the HCP Group Analysis Report bychanging the order of events in a column, adding and removing columns,and resizing columns. To save the custom changes, the user can clickCustomize (bottom right of screen). The Filter Builder screen displays(see FIG. 139). The user can then select Save As, enter a filename, andclick Save.

To reverse the order of items in any column, the user can click on thecolumn heading, then click on the little arrow that appears to the rightof the heading. The user can do the same to change the order back to itsoriginal sequence. To remove a column from the report, the user candrag-and-drop the column head cell off the table. To add a column to thereport, the user can right-click anywhere on the table to call up apop-up window (see FIG. 137), and select Customize Columns. TheCustomization list displays (see FIG. 138). From the list, the user canselect the column head you want to add. Then the user can drag-and-dropit to the preferred position in the column-head row. Two green arrowsdisplay to help the user position the column. FIG. 138 illustrates aCustomization List. To move columns left or right in the table, the usercan drag-and-drop the column-head cell to the preferred position in thecolumn head row. To adjust the width of any column, the user can use thesizing tool that becomes active when he or she hovers the pointer overthe right margin of the column-head cell.

Data Filter

For any column-head in the table, a user can configure a data filterusing the selection list. To display the selection list for any column,the user can click the down-arrow at the right. To display data for allpatients, with any or no entry in the corresponding data field, the usercan click All. To customize the data filter, the user can clickCustomize, and complete the dialog box. FIG. 139 illustrates a FilterBuilder Screen. To display data for any patient with a particular valuein the corresponding data field, the user can click the value ofinterest. To save the data filter changes, the user can click Customize(bottom right of screen). The Filter Builder screen displays (see FIG.139). The user can select Save As, enter a filename, and click Save.

Insulin Management Tools

The System of the preferred embodiment incorporates insulin managementtools to make health management easier for Home and HCP users. TheSystem provides additional insulin management tools to support the HomeUser's healthcare. An Insulin Adjustment Table is used to determineinsulin dose adjustment based on a user's current blood glucose level.All values entered in this table should be determined by the HCP. APrescribed Plan table is used to store and review healthcare guidelinesestablished by the HCP. FIG. 140 illustrates a References Drop-Down Box.

Insulin Adjustment Table

The HCP first sets up the values in this table (see FIG. 141). Insulinadjustment may not be necessary for every Home user. The Glucose StartValue (mg/dL) in the table is the blood glucose level at which theinsulin dose should be increased. Beginning with this value, consecutiveblood glucose ranges are provided for each increase in insulin. Theseranges are determined by the value entered as the patient's InsulinSensitivity. The Insulin Dosage Amount is the amount of insulin abovethe patient's normal dose that should be taken when the patient's bloodglucose level falls within the range specified The Insulin AdjustmentTable is provided as a convenient reference, and entries made in thistable are generally not used by other application features.

Defining Insulin Adjustment

On the Home page, a user can select References on the main menu bar (seeFIG. 140). A user can select Insulin Adjustment Table from the drop-downlist, and the Insulin Adjustment Table displays. FIG. 141 illustrates anInsulin Adjustment Table. The user can set the Glucose Start Value(mg/dL) to the value determined by his or her HCP. The Glucose StartValue is used to set the lowest glucose value on the Insulin AdjustmentTable and indicates when to start adjusting the insulin dose. The usercan set the value of Insulin Sensitivity to the value determined by yourHCP. The Insulin Sensitivity value is used to set the increase in valuebetween each of the consecutive blood glucose ranges displayed.

Prescribed Plan

The Prescribed Plan is a table Home users can use to store and reviewguidelines from their HCP for Insulin type, dosage, and time of day,insulin sensitivity, medication type, dosage, and time of day,carbohydrates for each individual meal time, and/or ratio of amount ofinsulin per grams of carbohydrate. FIG. 142 illustrates a PrescribedPlan. Data for each of these items can be individually entered forbreakfast, lunch, dinner, bedtime, and a snack. Comments can also beadded. Once the Prescribed Plan is entered, a user can view the plan byreturning to this screen. A user can also print it out by clicking Printat the bottom of the screen.

Defining a Prescribed Plan

On the Home page, a user can select References on the main menu bar (seeFIG. 140). The user can select Prescribed Plan from the drop-down list.The Prescribed Plan screen (see FIG. 142) then displays. The user canselect an entry type from the Type drop-down list: Insulin orMedication. The user can select Insulin to record an insulin type anddose for each meal field. The user can select Medication to record amedication type and dose for each meal field where it is taken. The usercan enter the name of the Insulin or the Medication and the dosage inthe Item field. The user can select Ratio to record the optimummeal-based insulin-to-carbohydrate ratio. The user can selectCarbohydrates to record the optimum carbohydrate intake. The user canenter the desired number of grams of carbohydrate for each meal field.The user can select Sensitivity and enter the Insulin Sensitivity factorhis or her HCP calculated for the user. The user can enter any commentsin the Comments field (optional). By clicking OK, the plan is saved andthe Prescribed Plan window closes. (Or, to clear all data entered intothe plan, the user can click Reset.)

Insulin Sensitivity

Individuals with low insulin sensitivity usually need a higher insulindose to lower their glucose levels to acceptable levels than people withhigher insulin sensitivity. The user's insulin sensitivity is determinedby his or her HCP. The insulin-to-carbohydrate ratio is used todetermine how much insulin to administer per grams of carbohydrateseaten. A user's insulin-to-carbohydrate ratio is determined by his orher HCP.

Host

The Host System of the preferred embodiment resides on an Internetserver. The Host database stores data that has been synchronized withthe System data on a user's PC. Data stored on the Host can be sharedwith other users. A Home user can choose to share your data with his orher HCP or several HCPs. HCP users can share data with other HCPs. Ineither case, the user “invites” the other party to share data. The usersets up a Host Account if he or she wishes to use the Host'scapabilities. A Host Account defines access, privileges, and functionsassociated with a particular user.

Synchronization

Synchronization is the process whereby the System application on auser's PC connects to the Internet and transmits data and otherinformation between the user's program and the Host server.Synchronization matches and updates the data between the Systemapplication installed on the user's computer and the Host System.Following synchronization, new and modified data is reflected in boththe local System database and the database on the Host server.

Host Account Setup

The first time a user synchronizes with the Host, the Synchronize windowopens. The user can follow the steps on the screen, a Host account willbe created and a confirmation e-mail will be sent to the user. The usercan verify his or her Host account number by looking on the User Profilescreen. If a user selects an item from the Host drop-down menu, theSystem will try to open an Internet connection automatically. If theInternet connection cannot be opened this way, it can be opened manuallybefore selecting items on the Host menu.

The user can click the Synchronize icon or select Host on the main menubar and choose Synchronize from the drop-down box (Home version) orSynchronize Current HCP (HCP version).

FIG. 143 illustrates a Home User: Host Drop-Down Box (left), and HCPUser: Host Drop-Down Box (right). The End-User Agreement Screen willdisplay. The user can review the End-User Agreement (see FIG. 144), andclick Next to continue.

FIG. 144 illustrates a First Time Synchronization Screen. The userproceeds through the setup process on the screen. A password isestablished and a Host Account number is assigned to the user (which nowappears on his or her user Profile screen).

FIG. 145 illustrates a Host Account Number. The System then synchronizesthe user's account, and a summary of the synchronized data automaticallydisplays.

FIG. 146 illustrates a Synchronization Summary Screen. A confirmationmessage is sent to the user from the Host and to the user's e-mailaddress. FIG. 147 illustrates a Confirmation Message From the Host

Synchronizing with the Host

If the user has previously logged in and set up an account, he or shecan synchronize with the Host as follows. The user can click the icon orselect Host on the main menu bar and choose Synchronize from thedrop-down box (Home version) or Synchronize Current HCP (HCP version)(see FIG. 143). The System then automatically synchronizes the user'slocal and Host accounts (including all event and profile data). Asummary of the synchronized data automatically displays (see FIG. 146).

Synchronize All (Home Version)

In a single household, there may be more than one person with diabetesthat manages their diabetes using the System. For convenience, a Homeuser may synchronize the data for all the Home users using the System inthe household with a single click of the mouse. The user can select Hoston the main menu bar and choose Synchronize All from the Home user Hostdrop-down box (see FIG. 143). The System displays a list of all the Homeusers on your PC. Synchronization starts automatically. A blue progressbar indicates when synchronization is complete for each Home user'sdata.

Synchronize All HCP Users (HCP Version)

In a clinic, for example, there may be several HCPs using the sameSystem. For convenience, a HCP may synchronize the patient data for allthe HCPs using the System with a single click of the mouse. The user canselect Host on the main menu bar and choose Synchronize All HCPs fromthe drop-down box (see FIG. 143). The System displays a list of all theHCPs on your local system and the patients they manage. Synchronizationstarts automatically. A blue progress bar indicates when synchronizationis complete for each HCP's and patient's data.

Invitation to Share Data

Once the user (Home or HCP) sets up a Host Account, he or she canauthorize one or more HCPs to have access to the data. To do this, theuser can initiate an “invitation” to the HCP to share data via the Host.This notifies the Host that the user will allow the selected HCP to view(and in some cases, edit) their data.

There are several ways to invite an HCP to share data. The HCP may havea Host Account Once a user is logged in to the Host, he or she cansearch for the HCP using the HCP's State/Province or Host Accountnumber. The HCP may not have a Host Account In this case, the HCP'se-mail address is discovered and used. If the HCP fails to accept ordecline the invitation within 30 days, the invitation to share dataexpires. A user then can send another invitation to the same HCP after30 days.

Invitation to Share Data: HCP has a Host Account

From the Host menu on the main menu bar, the user can choose Invite toShare Data. FIG. 148 illustrates an Invite to Share Data (Home UserScreen, left; HCP User Screen, right). An Internet connection to theHost server will be opened and the screen illustrated at FIG. 149 willdisplay. The user can select the appropriate option. If the user doesnot know the HCP's Host Account number, he or she can select Search HostHCP database to find an HCP from the list of existing accounts, and thenclick next. On the next screen, the user can select the state/provincewhere the HCP is located.

FIG. 150 illustrates a Find HCP from Existing Accounts Screen. The usercan then click Search. HCPs from the selected state with a Host Accountwill be displayed. The user can then highlight the HCP he or she wantsand click Next. The screen for selecting Access Level displays.

FIG. 151 illustrates an Assign Access Level Screen. The user can selectRead-Only Access or Full Access (Read and Enter Data), and then clickSubmit. The Host then displays the Process Complete screen and sends aninvitation to share data to the HCP.

FIG. 152 illustrates a Process Complete Screen. If you know the HCP'sHost Account Number, he or she can select enter the Host HCP AccountNumber provided by the HCP.

FIG. 153 illustrates an Invite HCP to Share Data Screen. The user canclick Next. On the next screen, the user enters the Host HCP AccountNumber.

FIG. 154 illustrates an Enter Host HCP Account Number Screen. The usercan click Search. The HCP is displayed as the search result. If this isthe HCP the user is looking for, the user can click Next. The screen forselecting Access Level displays. The user can select Read-Only Access orFull Access (Read and Enter Data), and click Submit.

FIG. 155 illustrates an Assign Access Level Screen. The Host thendisplays the Process Complete screen and sends an invitation to sharedata to the HCP. FIG. 156 illustrates a Process Complete Screen

Accepting an Invitation from the Host to Share Data: HCPS Only

If a patient user issues an invitation to share their data with a user,the user will see a message in the Messages From CoPilot Host window asillustrated at FIG. 157. If the user fails to accept or decline theinvitation within 30 days, the invitation to share data expires. Theuser can double-click the message header to display the invitation toshare data. FIG. 158 illustrates an Invitation to Share Data (fromHost). To accept the invitation, a user can click Accept Invitation(bottom of screen). The Host will then synchronize with the user'ssystem, and the patient's data will be uploaded to Host computer. Asummary of the synchronized data then automatically displays. The usercan then click Close to exit. At this point, the user has successfullyaccepted the invitation and received the patient's data.

Invitation to Share Data: HCP does not have a Host Account

If the HCP does not have a Host Account, a user can send an e-mailinvitation to the HCP to share data if the HCP's Internet address(example: jsloane@aol.com) is known. From the Host menu on the main menubar, the user can choose Invite to Share Data. An Internet connection tothe Host server will open and the screen illustrated at FIG. 159 willdisplay. The user can select send an e-mail invitation to an HCP whodoes not have an existing account, and click next. When the next screenopens, the user can enter the Name and E-mail Address of the HCP he orshe wishes to invite.

FIG. 160 illustrates an E-mail Invitation to HCP with No Host Account.The screen for selecting Access Level displays. The user can selectRead-Only Access or Full Access (Read and Enter Data), and click Submit.

FIG. 161 illustrates an Assign Access Level screen. When the user clicksnext, the Host then displays the Process Complete screen. FIG. 162illustrates a process Complete Screen. The Host will send the HCP ane-mail inviting him/her to have access to the data. The messageinstructs the HCP to download the Management System, install thesoftware and set up a user profile, and synchronize with the Host andset up a Host Account. The user then makes note of the Invitation Codeincluded near the end of the e-mail. The Host will notify the user whenthe HCP has accepted the invitation to share data. If the user does notreceive this message within a reasonable period of time, the HCP shouldbe contacted directly.

Accepting an E-Mail Invitation to Share Data (HCPS Only)

When a user receives an e-mail invitation to share data, the messagewill instruct the user to download the Health Management System from theInternet (e.g., by just clicking on the hyperlink in blue), install thesoftware and set up a user profile, and synchronize with the Host andset up a Host Account. The user then makes note of the Invitation Codeincluded near the end of the e-mail (see FIG. 164). FIG. 163 illustratesan E-mail Invitation to Register and Share Data. An invitation code maylook like that illustrated in FIG. 164.

After the user has downloaded and installed the software, he or she canset up a user profile and register with the Host. From the Hostdrop-down box on the main menu bar, the user can choose Accept E-MailInvitation. FIG. 165 illustrates a HCP: Host Drop-Down List. The Systemconnects to the Host server and the screen illustrated at FIG. 166displays. The user can enter the Invitation Code in the box provided andclick Next. The Host then synchronizes with the user's System, and thepatient's data is downloaded. A summary of the synchronized data thenautomatically displays. A synchronization screen is illustrated at FIG.167.

Managing Shared Data: Home User

A user can limit, expand, or deny an HCP access to his or her data onthe Host using a Manage Shared Data function.

Defining or Changing HCP Access to Data

From the Host drop-down box (see FIG. 168) on the main menu bar, theuser can choose Manage my shared data. The next screen shows a list ofeach authorized HCP along with the level of access granted to them. FIG.169 illustrates a Manage My Shared Data Screen. The user can highlightthe HCP whose access he or she wishes to change and choose to Grant NOAccess which removes all access to your data by the listed HCP, GrantRead-Only Access, which restricts the HCP to viewing your data, or GrantFull Access, which allows the HCP to view and edit the data, includingevent data, glucose targets, the user's prescribed plan, etc. The usercan click Close to exit, and the Host the sends a message to the HCPabout the changed access level.

Managing Shared Data: HCP User

A HCP user can view a list of the patients with whom he or she sharesdata. The HCP user can also unsubscribe patients, which means the HCPuser will no longer have access to their data. From the Host drop-downbox (see FIG. 170) on the main menu bar, the HCP user can choose Managedata being shared with me (see FIG. 171). The next screen shows a listof the patients who share data with the HCP user. The HCP user can thenhighlight the patient that he or she wants to unsubscribe. Then, the HCPuser can click the Unsubscribe button (lower left of screen). The AccessLevel for this patient will change to NONE. The Host will send a messageconfirming the changed Access Level. The next time the patient or theHCP who assigned the patient to synchronize with the Host, the AccessLevel on their Manage My Shared Data screen will be NONE. FIG. 172illustrates a Changed Access Level Message.

Database Management

To ensure that information remains accurate, the System provides theuser with the capability to perform database maintenance. The DatabaseMaintenance feature includes the ability to, archive data, backup dataand restore data from the last backup. More than one database can becreated and maintained by the System application. The last databaseselected will be opened by each successive execution of the softwareuntil another database is selected by the user.

Archiving Data

When a user chooses to archive data, the data being archived will beremoved from the System database. The user can restore the data byimporting it. On the Home page, the user can select Database Maintenancefrom the File drop-down box (see FIG. 173). The user can select theArchive option from the menu. A window will open, allowing the user tospecify a date. The user can select the last date of the data to beincluded in the archive, and click OK. FIG. 174 illustrates an ArchiveEvent Data Screen. A file browser will open. The user can browse to thedirectory where the file is to be saved. The user should make sure XMLfile (*.xml) is displayed in the Save as Type window. FIG. 175illustrates a File Browser Window: Save Archive Data. The user can enterthe name of the file in the File Name window and click Save. The file issaved as an .xml file in the directory specified.

Viewing Archived Data

The user can close or minimize the system application. The user opensthe file browser and browses to the folder where he or she saved thearchived *.xml file. FIG. 176 illustrates a File Browser: Location ofArchived Data File (*.xml). To open an *.xml file, a Web browser (forexample, Internet Explorer, Netscape, etc.) is used that is installed onyour PC. The user can highlight the archive file and click Open.

Restoring Archived Data

Archived data can be reloaded into the System as follows. On the Homepage, a user can select Import from the DataEntry drop-down box (seeFIG. 177). The user can choose Import Events from File from the Importsubmenu. A file browser opens. The user can browse to the directorywhere the file is located. The user can select the file type (*.xml or*.tab) in the Files of Type window. The user can Highlight the file andclick Open. Importing will automatically begin. The Importing progressscreen (see FIG. 178) displays the progress of the import procedure. TheImporting screen closes when data import is finished.

Backing Up the Database

A backup of the database is performed automatically each time the userexits (closes) the application. The user can also create a backup of hisor her database at any time and save it in any directory. The user canBackup the database as follows. On the Home page, the user can selectDatabase Maintenance from the File drop-down box (see FIG. 173). Theuser can choose Backup from the Database Maintenance submenu. A filebrowser opens. The user can browse to the directory where he or shewants the file to be located. FIG. 179 illustrates a File Browser:Select Backup Location. The user makes sure that the words System (orother designated name such as FreeStyle CoPilot) Backup File aredisplayed in the Save as Type window. The user can then enter the nameof the file in the File Name window and click Save.

Restoring a Backed Up Database

The System database is automatically restored if a system integritycheck fails. A user can also restore a database whenever desired, asfollows. On the Home page, the user can select Database Maintenance fromthe File drop-down box (see FIG. 173). The user can choose Restore fromthe Database Maintenance submenu. A file browser opens. The user canbrowse to the directory where the database was saved. The checks to makesure the words System or FreeStyle CoPilot Backup are displayed in theFile of Type window. The user enters the name of the file in the FileName window and clicks Open. The Restore Log then displays asillustrated at FIG. 180, showing the restored transactions.

Viewing the Restore Log

The user can view the Restore Log at any time, as follows. The user canclose or minimize the System application. The user can open the filebrowser and find the Health Management System folder. This is the folderwhere the application was installed. FIG. 181 illustrates a FileBrowser: Restore Log. The user can highlight the file named Restore logand click Open to view the log.

Help

For answers to questions about how to do something within the System, auser can consult the User's Guide or take advantage of the System'sbuilt-in onscreen Help. The user can access Help from any screen in theSystem that displays the main menu bar. The user can getcontext-sensitive Help on most screens. For example, if the user isviewing the Diary List and has a question, he or she can click WY. TheHelp screen will automatically open to the Help text that describes theDiary List.

Accessing On-Screen Help

On the Home page, a user can click an icon, or select Help on the mainmenu bar and then select Contents from the drop-down list (see FIG.182). FIG. 183 illustrates a Help Screen that would then display.

Help Screen

Help text is displayed in the large window on the Help screen. TheContents, Index, and Search tabs at the left offer three ways to findthe Help topic the user is looking for. When the user selects a topic,the Help text appears in the large window on the right. Some text maycontain links to more detailed information about a topic. These linksappear as blue text followed by three dots (for example, Local Home UserAccount . . . ). If it is a link, the cursor will change from an arrowto a hand when passed over the link. The user can click the link to seethe additional text. Green text may be underlined and in italics. If itis a link, the cursor will change from an arrow to a hand when passedover the link. The user can click the link to see the additional text.

Help Screen Icons

The user can click to hide the column with the Contents, Index, andSearch tabs from displaying on screen. The user can click to show thecolumn with the Contents, Index, and Search tabs. The user can click tosee the previous page in the Help text. The user can click to see thenext page in the Help text, and can click to print the Help page beingviewed.

Contents Tab

Contents is the first tab displayed when the user opens the Help screen(see FIG. 183). This is the table of contents for the Help file. TheHelp information is arranged by topic here. The user can double-click ona topic listed (for example, Getting Started) and subsections willdisplay. Some of the subsections have further subsections.

Index Tab

The user can click on the Index tab to display an alphabetical list ofall topics covered in the Help file. The user can select a topic fromthe list and double-click. The text displays in the big window (see FIG.183). FIG. 184 illustrates a Help: Index Tab. Alternatively, a user cantype a keyword into the Type in the keyword to find: field. Then clickthe icon at the bottom of the screen. A list of Help topics matching thekeyword displays. The user can select a topic and double-click. The textdisplays in the big window.

Search Tab

The user can click on the Search tab if he or she wants to use keywordsto find Help text. FIG. 185 illustrates a Help: Search Tab. To search,The user can type a keyword into the Type in the keyword to find: field.Then click the icon. A list of topics related to your keyword displaysin the Select Topic to Display window. The user can select a topic anddouble-click (or select a topic and click the icon. The text displays inthe large window. The user can also contact Technical Support andService (see FIG. 186 which illustrates a Help Drop-Down Box). ACustomer Service Contact Information screen displays (see FIG. 187). Thescreen shows the ways a user can get help if he or she has questionsabout using the System, such as On-Line Help, E-Mail Customer Service,and Customer Service Hotline. FIG. 187 illustrates a Customer ServiceContact Information Screen.

The present invention is not limited to the embodiments described aboveherein, which may be amended or modified without departing from thescope of the present invention as set forth in the appended claims, andstructural and functional equivalents thereof.

In methods that may be performed according to preferred embodimentsherein and that may have been described above and/or claimed below, theoperations have been described in selected typographical sequences.However, the sequences have been selected and so ordered fortypographical convenience and are not intended to imply any particularorder for performing the operations.

In addition, the following references, in addition to the summary of theinvention section, are hereby incorporated by reference into thedetailed description of the preferred embodiments as disclosingalternative embodiments:

U.S. Pat. Nos. 5,307,263, 5,899,855, 6,186,145, 5,918,603, 5,913,310,5,678,571, 5,822,715, 5,956,501, 6,167,362, 6,233,301, 6,379,301,5,997,476, 6,101,478, 6,168,563, 6,248,065, 6,368,273, 6,381,577,5,897,493, 5,933,136, 6,151,586, 5,960,403, 6,330,426, 5,951,300,6,375,469, 6,240,393, 6,270,455, and 6,161,095;

United States published applications no. 2001/0011224, 2003/0163351, and2003/0069753;

U.S. patent applications Nos. 60/577,064 and 10/112,671; and

Internet web sites: www.freestylecopilot.com,www.abbottdiabetescare.com, www.lifescan.com/care, www.bddiabetes.com,www.roche-diagnostics.com, www.healthhero.com, and www.minimed.com.

1-49. (canceled)
 50. A method of operating a diabetes care datamanagement system having a display, a user interface, a processor, amemory and a user input device, the method comprising: measuringdiabetes care data of a user with a diabetes monitoring device;associating the diabetes care data with an event; displaying a reportcomprising the diabetes care data; saving to the memory the reportcomprising the diabetes care data associated with the event.
 51. Themethod of claim 50, further comprising separating the diabetes care datainto one or more groups based on the event.
 52. The method of claim 51,wherein the event comprises one or more of a date, a time, a timeperiod, a sample site, a glucose reading, a glucose control reading, atime since last meal, a calibration code, an insulin dose, a meal value,an exercise session, a state of health, a health condition, a medicationdose, a medical examination, a laboratory result, a ketone reading, aketone control reading, and a note.
 53. The method of claim 52, whereinthe event comprises the date and the time.
 54. The method of claim 53,wherein the one or more groups comprise a user selectable time period.55. The method of claim 54, wherein the user selectable time periodcomprises a pre-meal time period and a post-meal time period.
 56. Themethod of claim 54, wherein the user selectable time period comprisesone or more of a pre-breakfast time period, a post-breakfast timeperiod, a pre-lunch time period, a post-lunch time period, a pre-dinnertime period, a post-dinner time period, a bed time period, and a sleeptime period.
 57. The method of claim 50, wherein the diabetes monitoringdevice comprises a blood glucose meter.
 58. The method of claim 50,further comprising displaying a graphical user interface comprising auser selectable option.
 59. The method of claim 58, further comprisinghighlighting the user selectable option.
 60. The method of claim 58,wherein the user selectable option comprises a drop-down menu, an icon,a tab, a toolbar, a triangle, an up arrow, a down arrow, an OK button,or a cancel button.
 61. The method of claim 58, wherein the userselectable option comprises a selectable date range for the report, andwherein the report comprises the diabetes care data within the selecteddate range.
 62. The method of claim 58, wherein the user selectableoption comprises a device setup selection.
 63. The method of claim 50,further comprising indicating when the diabetes care data is outside theworking range of the diabetes monitoring device.
 64. The method of claim50, further comprising generating the report based on selection criteriafor application in the report.
 65. The method of claim 64, wherein theselection criteria comprises patient profile information, demographicinformation, data event types, a range of values, dates, or combinationsthereof.
 66. The method of claim 50, where the report comprises anaverage of the diabetes care data.